Penile prosthesis

ABSTRACT

A penile prosthesis which is adapted to be surgically implanted in man for the treatment of erectile impotence includes a penile implant comprising an elongated, flexible cylindrical member having a short relatively stiff proximal portion which is adapted to be implanted into the root end of the corpus cavernosum to support the implant and an elongated flexible distal portion having a non-distensible tubular chamber substantially filled with a non-compressible fluid and a conical tip. The distal section is adapted to be implanted into the corpus cavernosum of the pendulus penis with the conical tip in the distal end of the corpus cavernosum. The prosthesis also includes means for completely filling and pressurizing the chamber to make rigid the non-distensible distal portion. In one embodiment the chamber is filled and pressurized by squeezing the chamber and reducing its volume and in another it is filled and pressurized by transferring additional fluid under pressure into the chamber.

This is a division of application Ser. No. 313,729, filed Oct. 22, 1981,now U.S. Pat. No. 4,378,792, which is a division of application Ser. No.150,231, filed May 15, 1980, now U.S. Pat. No. 4,318,396.

The present invention relates to a penile prosthesis. More particularly,it relates to a penile prosthesis which is adapted to be implanted inman for treatment of erectile impotence.

BACKGROUND OF THE INVENTION

There are instances of erectile impotence in which the patient does notrespond to more conventional therapy and the surgical implanting of apenile prosthesis may be the only practical means of remedying theimpotency.

Several types of penile prostheses have been employed in the past. Onetype of penile prosthesis is a pair of rods of suitable stiffness whichare surgically implanted into the corpus cavernosum of the penis. Onedisadvantage of some of the rod-type implants is the permanent stiffnessof the rod which can be a source of physical pain and/or embarrassmentto the patient. The prostheses disclosed in U.S. Pat. No. 3,893,476 andU.S. Pat. No. 4,066,037 are representatives of the rod type prostheses.

Another type of penile prosthesis which is available is the inflatableprosthesis. The most common inflatable prosthesis includes two fairlylong inflatable and distensible tubes that are surgically implanted inthe corpus cavernosum of the penis. Each of the two tubes is connectedby tubing to a pressure bulb of inflating fluid which is implantedelsewhere in the body. Because of the volume required to inflate,distend, pressurize and rigidize the inflatable tubes, the pressurebulbs are relatively large. The prostheses of U.S. Pat. No. 3,954,102and U.S. Pat. No. 4,009,711 are representatives of the inflatable typeprostheses.

SUMMARY OF THE INVENTION

It is the general object of the present invention to disclose a new typeof penile prosthesis.

The penile prosthesis of the present invention comprises a pair ofpenile implants. Each of the implants is a flexible, elongated memberhaving a short, relatively stiff proximal stem which is adapted to beimplanted into the root end of the corpus cavernosum to support theimplant and an elongated flexible, non-distensible distal portion havinga chamber substantially filled with a non-compressible fluid and aconical tip. The distal portion is adapted to be implanted in the corpuscavernosum of the pendulus penis with the conical tip in the distal endof the corpus cavernosum. The implant also includes means for completelyfilling and pressurizing the chamber to make rigid the non-distensibledistal portion and to stiffen the penis. In one embodiment, the chamberis filled and pressurized by squeezing the chamber and reducing itsvolume and in another it is filled and pressurized by transferringadditional fluid under pressure into the chamber.

The proximal stem of the implant is relatively stiff so that when it isimplanted into the root end of the corpus cavernosum it will anchor andsupport the implant and the distal portion and tip of the implant aresoft so as to cause a minimum of irritation to the tissue of the penis.The distal portion which contains the chamber substantially filled withnon-compressible fluid is flexible and when not pressurized permits thependulus penis to assume a normal flaccid position. The tip of thedistal portion of the implant is paraboloidal in shape to fit the end ofthe corpus cavernosum, and to enhance the physiological compatibility ofthe implant.

The means for completely filling and pressurizing the chamber to makethe non-distensible distal portion rigid and to effect an erection maybe a clamp or other means for squeezing, compressing the chamber andreducing its effective volume or a valve or port which permits thechamber to be filled by the transfer of additional fluid under pressureinto the chamber.

Further objects and advantages of the prosthesis of the presentinvention will become apparent from the drawings and the description ofthe preferred embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view, partly in section, of a penile prosthesis of thepresent invention in a non-pressurized condition surgically implanted ina male;

FIG. 2 is a side view similar to FIG. 1, except that the prosthesis ispressurized;

FIG. 3 is a cross sectional view taken along the line 3--3 in FIG. 1;

FIG. 4 is a cross sectional view taken along the line 4--4 in FIG. 2;

FIG. 5 is a top plan view, partly in section, of another form of implantwhich can be used in the prosthesis of the present invention;

FIG. 6 is a cross sectional view taken along line 6--6 in FIG. 5;

FIG. 7 is a side view, partly in section, of an implant which can beused in a second embodiment of the prosthesis of the present invention;

FIG. 8 is a side view similar to FIG. 7 except that the implant ispressurized.

FIG. 9 is a cross sectional view taken along line 9--9 in FIG. 7;

FIG. 10 is a side view, partly in section, of another implant which canbe used in the second embodiment of the present invention; and

FIG. 11 is a side view similar to FIG. 10 except that the implant ispressurized.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

As seen in FIGS. 1-4, one embodiment of a penile prosthesis 10 comprisesa pair of elongated cylindrical members 11, 11¹ of a physiologicallyinert material such as medical grade silicone rubber. The two implants11, 11¹ are identical and only one will be described in detail. Theimplant 11 has a short, proximal stem 12 of relatively stiff materialwhich is implanted in the root end of the corpus cavernosum to supportand anchor the implant, an intermediate tubular portion 13, and aconical distal tip 14. The tubular portion 13 and the tip 14 are ofsoft, flexible material and they are implanted into the corpuscavernosum of the pendulus penis. The tip 14 is paraboloidal in shape toconform to the inner shape of the end of the corpus cavernosum. As seenin FIGS. 2 and 4, there are two implants 11, 11¹. Each of the implants11, 11¹ is implanted in a corpus cavernosum of the penis.

The intermediate tubular portion 13 of the implant 11 includes a tubularsleeve 15, preferably of a silicone coated mesh or woven fabric, whichis sealed at its ends 16 and 17 to the stem 12 and tip 14, respectively,in a fluidtight manner to form a cylindrical non-distensible chamber 18.The seals 16, 17 may be made with a suitable adhesive or by otherconventional means. As seen in FIG. 1, in its non-pressurized state thechamber 18 is substantially filled with a non-compressible fluid 19,such as saline or a free flowing silicone gel.

Referring specifically now to FIGS. 1 and 3, it can be seen that whenthe chambers 18, 18¹ containing the non-compressible fluid 19 are notpressurized, the soft, flexible, non-distensible, intermediate tubularportion 13 of the member 11 permits the penis to assume a substantiallynormal, flaccid position. However, when as seen in FIG. 2 the chambers18, 18¹ are filled and pressurized, they cause the penis to assume anerectile position.

As seen in FIGS. 1 to 4, a clamp 20 is implanted in an operativeposition about the prosthesis 10. When the clamp 20 is open, as in FIG.2, it exerts no compressive force on the chambers 18, 18¹, but when itis closed as in FIG. 4 the clamp 20 squeezes or exerts a compressiveforce on the chambers 18, 18¹ and the fluid 19, 19¹ thereby reducing theeffective internal volume of the chambers 18, 18¹ and causing theimplants 11, 11¹ and penis to assume the pressurized erectile positionseen in FIG. 2.

Referring now to FIGS. 3 and 4, it can be seen that the clamp 20 isbasically a modified C clamp with a compressive pad 21, 22 positionedintermediate the length of each arm 23, 24. The arms 23 and 24 arehinged together at one end, respectively, by a hinge pin 20a and theother ends of the arms 23, 24 are provided with magnets 25 and 26 ofopposite polarity which are attracted to each other. The hinge pin 20ais removable so that the clamp 20 can be disassembled for implanting andthen reassembled.

As seen in FIG. 3, the pads 21 and 22 and the magnets 25 and 26 arenormally maintained in a spaced apart position. However, when themagnets 25 and 26 are physically moved together they are retained inthat position, as seen in FIG. 4, as a result of their magneticattraction for each other. To facilitate opening the clamp 20, keepingit open, and preventing tissue from growing between the magnets 25, 26and otherwise interfering with the operation of the clamp 20, the endsof the arms 23, 24 and the magnets 25, 26 are preferably enclosed in aflexible walled capsule 27 which may contain a fluid 28.

The chambers 18, 18¹ of the implants 11, 11¹ are filled and pressurizedby manually forcing the magnets 25 and 26 of opposite polarity towardeach other thus squeezing and compressing the walls of the chambers andreducing the effective volume of the chambers 18, 18¹, so that they arecompletely filled and also exerting pressure on the fluid 19, 19¹.Because of their magnetic attraction the magnets 25 and 26 do notnormally return to their original position. When it is desired todepressurize the implants 11, 11¹, the clamp 20 is opened by squeezingthe fluid filled capsule 27. The fluid pressure thus generated forcesthe magnets 25 and 26 back to their original spaced apart relationshipand helps maintain them in that position. If desired a spring (notshown) can be included in the hinge of the clamp 20 to assist in keepingthe clamp 20 open.

The unique combination of the penile implants 11, 11¹ which include thetubular non-distensible chambers 18, 18¹ substantially filled withnon-compressible fluid 19, 19¹ and the clamp 20 for exerting pressure onthe chambers 18, 18¹ eliminates the need for separate bulbs ofpressurizing fluid which were required with prior art inflatable penileprostheses.

A second embodiment of the invention which might be preferred for someuses is shown in FIGS. 5 and 6. As seen therein, an implant 100comprises a unitary member having a pair of stems 101, 101¹ at thedistal end and a pair of tips 102, 102¹ at the proximal end. The implant100 has an intermediate non-distensible chamber 103 filled with fluid104. As seen in FIG. 6, the chamber 103 is shaped to fit into the corpuscavernosum and is partitioned as at 105. The implant 100 may be combinedwith a clamp similar to that previously described or other means forsqueezing the chamber 103 to provide a complete penile prosthesis.

Another second embodiment of the prosthesis of the present invention isshown in FIGS. 7 to 11. In the embodiment seen therein thenon-distensible chamber is filled and pressurized by the transfer ofadditional fluid into a non-distensible chamber.

Referring now to FIGS. 7, 8 and 9, there can be seen an implant 200 witha stem 201 at the proximal end and a tip 202 at the distal end.Positioned intermediate the stem 201, which is hollow as seen in FIG. 9,and the tip 202 is a first bulbar chamber 203 and a second tubularnon-distensible chamber 204. Fluid transfer between the chamber 203 andthe second chamber 204 is controlled by a two-way valve 205. A secondtwo-way valve 206 controls fluid flow between the stem 201 and the firstchamber 203. As seen in FIG. 7, the hollow stem 201 and the chambers 203and 204 are all substantially filled with a non-compressible fluid 207.When it is desired to pressurize the second non-distensible chamber 204,the bulbar chamber 203 is forcibly squeezed manually forcing fluid 207under pressure through the valves 206 and 205 into the chamber 204,causing it to fill and stiffen and the stem 201 and chamber 203 topartially collapse as seen in FIG. 8. Upon release of the squeezingforce, the valves 205 and 206 closed. When it is desired to relieve thepressure in the chamber 204, the valves 205 and 206 are manuallymanipulated to an open position. In order to provide a complete penileprosthesis, two of the implants 200 are employed.

A large variety of different types of valves can be used as the valves205 and 206 in the implant 200, including those disclosed in U.S. Pat.No. 4,009,711. Preferrably, the valves are of the type which open whenthe stem 201 or chamber 203 are squeezed, which close automatically whenthe squeezing stops and which can be opened by manipulation from theoutside.

Another type of implant that can be used in the second embodiment of theinvention is seen in FIGS. 10 and 11. The implant 300 as seen thereinhas a stem 301 at the distal end, a tip 302 at the proximal end and apair of intermediate chambers 303 and 304 separated by a wall 305 havinga port 306. As seen in FIG. 10 both chambers are substantially filledwith a non-compressible fluid 307. The larger chamber 303 which isnon-distensible is filled and pressurized to stiffen the distal portionof the implant 300 by manually moving the wall 305 toward the proximalstem 301 to transfer fluid 307 from the smaller chamber 304 into thechamber 303. As the wall 305 is moved, the smaller chamber 304 isemptied and collapses; it is held in the collapsed position seen in FIG.11 by cooperation of the male member 308 and the female socket 309 whichare manually engaged. When it is desired to depressurize the chamber303, the male member 308 is manually disengaged from the female socket309. Other locking means for holding the chamber 304 in the collapsedcondition can be employed provided the means can be engaged anddisengaged by manual manipulation from the outside. In order to providea complete penile prosthesis, two of the implants 300 are employed.

The novel prosthesis of the present invention which has been describeddiffers primarily from prior art inflatable prostheses in that the wallsof the fluid containing chambers of the novel implants arenon-distensible, i.e., they do not stretch or inflate. Other importantdifferences are that the chambers even in the non-pressurized conditionare substantially filled with non-compressible fluid so that relativelylarge separate pressure bulbs are not required to pressurize thechamber. If it is desired to use pressure bulbs to pressurize thesubstantially fluid filled non-distensible chambers of the implants ofthe present invention the bulbs need be of only minimal size.

The term "substantially filled" as used herein to described the fluidcontent of a chamber means that the chamber contains about 60% to about95% or more of its capacity of a non-compressible fluid such as water,saline or a free flowing gel. The actual content of fluid can vary;however, the distal portion of the implant when "substantially filled"should be still sufficiently flexible so that the penis can assume anormal flaccid position.

All the parts and components of the prosthesis are preferrably made ofor covered with medical grade silicone rubber which is non-reactive,non-toxic and well tolerated by the adjacent organic tissues. Siliconerubber is preferred because it is quite resistant to wear and tear andremains functional for long periods of time. However, other suitablematerials possessing desirable properties also can be employed.

The sleeves which form the walls of the "non-distensible" chambers arepreferably made of a mesh or fabric covered with silicone material sothat they will not stretch when filled with fluid and excessive pressurewill not be exerted on the tunica albuginea. The diameters of thesleeves are selected so that the implants fill the corpus cavernosumwhen the implants are in their pressurized state.

The proximal stems of the implants preferrably have a Shore A hardnessof about 70, the distal tips a Shore A hardness of about 20, and each ofthe materials have sufficient tensile strength for its intended use.

The preferred method of implantation of the prosthesis is through anincision made at the penoscrotal junction. After appropriate incision,the corpus cavernosum is dilated distally and proximally to accept theimplant. The appropriate anatomical measurements are made to insure thatthe proximal stem of a particular implant will be positioned at the baseof the penis below the pelvic bone. An implant having an appropriatelysized intermediate section and distal tip is inserted into the corpuscavernosum of the penis. The distal tip is positioned in the tunica endof the corpus cavernosum. The proximal stem of the implant then isanchored in the root end of the corpus cavernosum.

The identical procedure is performed on the other side of the penis tocomplete the surgical procedure. The proximal stems of the two implantspreferably will diverge laterally to accommodate the anatomy and providelateral stability to the penis. When the embodiment utilizing a clamp isemployed, the clamp is implanted at the same time and the incision isthen closed.

It will be apparent to those skilled in the art that use of thenon-distensible chamber in the penile implant of the present inventionpermits the pressure in the chamber to be raised to the proper levelwith the least amount of fluid. Prior art prostheses employingdistensible chambers need large amounts of fluids to pressurize to theproper level thus requiring large fluid reservoirs.

It is to be understood that the foregoing description has been forpurposes of illustration and that a number of modifications and changesmay be made without departing from the spirit and scope of the presentinvention. Therefore, the invention is not to be limited by any of thespecific embodiments described but only by the claims which follow:

I claim:
 1. An implantable penile prosthesis for implanting completelywithin a patient's penis comprising at least one elongated member havinga flexible distal forward section for implantation within the pendulouspenis, said forward section being constructed to rigidize upon beingfilled with pressurizing fluid; a proximal, rearward section adapted tobe implanted within the root end of the penis, said rearward sectioncontaining a fluid reservoir chamber; externally operable pump means insaid member for transferring fluid under pressure to said flexibledistal forward section of said member for achieving an erection; andvalve means positioned within said member which open when said pump isoperated so that fluid is forced from said pump through said valve meansinto said flexible distal forward section of said member.
 2. Animplantable penile prosthesis of claim 1 in which the flexible distalforward section of the member includes a non-distensible pressurechamber.